The Dutch self-regulatory Code of Conduct for Medical devices (Gedragscode GMH, GMH) contains several new requirements concerning interactions between medical device companies and healthcare professionals (HCPs) which apply as of 1 January 2015. Maximum hourly rates for payment to HCPs have been introduced and sunshine/transparency rules will start to apply to certain interactions with HCPs.
Hourly rates for services rendered by HCPs
The GMH specifies maximum hourly rates that may be paid to HCPs as reasonable remuneration for their services. These hourly rates follow the hourly rates as applicable to the pharmaceutical industry.
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Disbursements of HCPs
The GMH provides for the following reasonable travel disbursements:
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Introduction of sunshine requirements
As of 1 January 2015 sunshine requirements have been introduced in the GMH. In a letter to Dutch parliament dated 14 January 2015 the Minister of Health (MoH) endorses the introduction of sunshine requirements in the medical devices industry. At the same time the MoH acknowledges that it may be too burdensome to introduce sunshine obligations for the entire field. An obligation to disclose financial relations has terefore - as a pilot project - been introduced for a limited number of implantable medical devices and HCPs. The obligation to disclose financial relations applies to services and sponsoring of projects/activities over 2015, between:
- Physicians thate are included in the Dutch public register of HCPs (BIG-register) with the title "cardiology"or "orthopaedics"; and
- Suppliers of the following implantable medical devices: Implantable Cardioverter Defibrillators (ICDs), pacemakers, stents and/or hip and knee prostheses.
No sunshine obligations apply for other financial relations between suppliers of medical devices and HCPs. It may however be decided in the future that the sunshine obligation will be extended to cover other medical devices and HCPs as well. In light hereof the GMH provides that as of 1 January 2015 it is prohibited to include provisions in an agreement that may be an obstacle for current and future obligations to disclose financial relations based on the GMH. In the meantime voluntary disclosure of financial relations is encouraged by the GMH.
The obligation to disclose payments applies if the total amount exceeds EUR 500 per calender year. The first disclosure of 2015 payments shall take place in 2016 in the Dutch Transparency Register and shall contain: inter alia, the following data: amount paid, type of agreement (sponsoring or services), data regarding supplier and HCP, i.e. name, address details. The publicly accessible Transparency Register has since 2013 been used in the Netherlands to disclose payments regarding relations between pharmaceutical companies and HCPs and will as of 2016 be extended to also cover medical devices.